The Missing Patient Voice in Drug|Safety Reporting

The Missing Voice of Patients in Drug-Safety Reporting

The graphs reflect the incidence of moderate-severity symptoms according to the CTCAE and show that patients report symptoms earlier and more frequently than do ...

The Missing Patient Voice in Drug-Safety Reporting - PMC

Prospectively collecting data directly from patients about symptoms they experience while taking a drug (so-called adverse symptom events) is an alternative ...

The Missing Voice of Patients in Drug-Safety Reporting

this information, largely collected during clinical trials, is based almost entirely on clinicians' impressions of patients' symptoms — not on patients' own ...

The missing voice of patients in drug-safety reporting - PubMed

The missing voice of patients in drug-safety reporting.

The Missing Voice of Patients in Drug-Safety Reporting

Safety monitoring during the early postmarketing period is crucial to detect rare, serious, or pediatric-specific adverse events. Fortunately, the majority of ...

The Missing Voice of Patients in Drug-Safety Reporting - ProQuest

The Missing Voice of Patients in Drug-Safety Reporting. Basch, Ethan, MD. The New England Journal of Medicine; Boston Vol. 362, Iss. 10, (Mar 11, 2010): 865 ...

The missing voice of patients in drug-safety reporting.

A drug label's “Adverse Reactions” section is based almost entirely on clinicians' impressions of patients' symptoms, but Dr. Ethan Basch argues for ...

The Missing Voice of Patients in Drug-Safety Reporting

this information, largely collected during clinical trials, is based almost entirely on clinicians' im- pressions of patients' symptoms.

The missing voice of patients in drug-safety reporting | ID ...

The missing voice of patients in drug-safety reporting. ... A patient wants to know about symptoms she may have from a prescription drug she is taking ...

Voice of patients missing in adverse event reporting - Relias Media

Rather than blind, call it a "deaf spot." The adverse event reporting from clinical trials that helps inform conclusions about a drug's safety has a crucial ...

The Missing Voice of Patients in Drug-Safety Reporting - SEARCH

A drug label's “Adverse Reactions” section is based almost entirely on clinicians' impressions of patients' symptoms. Dr. Ethan Basch argues for collecting ...

The Missing Voice of Patients in Drug-Safety Reporting

The Missing Voice of Patients in Drug-Safety Reporting ; dc.creator, Basch, Ethan, en ; dc.date.accessioned, 2016-01-09T00:41:57Z, en ; dc.date.available, 2016-01- ...

The Missing Voice of Patients in Drug-Safety Reporting - KP Bibliotek

The current drug-labeling practice for adverse events is based on the implicit assumption that an accurate portrait of patients' subjective experiences can be ...

The Missing Voice of Patients in Drug-Safety Reporting

The Missing Voice of Patients in Drug-Safety Reporting. Creator. Basch, Ethan. Bibliographic Citation. New England Journal of Medicine 2010 March 11; 362(10): ...

When Patient Voices Get Lost in Evidence Hierarchies: A Testimony ...

If so, these experiences never become part of the body of patient-produced evidence about potential adverse drug reactions, and thus outlier patients are ...

PRO-CTCAE Provides "Missing Patient Voice" in Reporting Cancer ...

This “patient voice” is especially important since the 2009 U.S. Food and Drug Administration (FDA) final guidance document recommends that ...

Unintended ignorance: The narrative of 'the missing patient voice'

The frictions between the various patient voices represented through the care workers gave 'the missing patient voice' label authority to speak or act on behalf ...

Beyond the FDA PRO Guidance: Steps toward Integrating ...

5. Basch, E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010; 362:865- ...

Project Patient Voice | FDA

The drug under study may or may not have caused these adverse events. The information on Project Patient Voice is from the same trial but ...

Integrating the patient voice with clinician reports to identify a ...

Incorporating patient reporting of symptomatic adverse events (AEs) is important in evaluating safety and tolerability in cancer clinical ...